John MCINTYRE

Patent Trials and Appeals Board

Jun 10, 2020

2020000157 (P.T.A.B. Jun. 10, 2020)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/554,497 09/04/2009 John A. MCINTYRE 20415-135721-US 8660
42798 7590 06/10/2020
FITCH, EVEN, TABIN & FLANNERY, LLP
120 South LaSalle Street, Suite 2100
Chicago, IL 60603-3406
EXAMINER
EMCH, GREGORY S
ART UNIT PAPER NUMBER
1699
MAIL DATE DELIVERY MODE
06/10/2020 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN A. MCINTYRE1
Appeal 2020-000157
Application 12/554,497
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
Opinion for the Board filed by Administrative Patent Judge GRIMES.
Opinion Dissenting filed by Administrative Patent Judge FREDMAN.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of diagnosing Alzheimer’s disease, which have been rejected as
being ineligible for patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as REDOX-REACTIVE
REAGENTS, LLC. Appeal Br. 1. We use the word Appellant to refer to
“applicant” as defined in 37 C.F.R. § 1.42(a).
Appeal 2020-000157
Application 12/554,497

2
STATEMENT OF THE CASE
The Specification describes “autoantibodies that are produced when
they undergo an oxidation-reduction reaction, nam[ed] . . . redox-reactive
autoantibodies (R-RAA).” Spec. 20:1–3. “These antibodies display no
autoantibody reactivity in their native state. However, in the laboratory,
these antibodies can undergo a redox reaction wherein they lose an
electron(s) to an oxidizing agent such as hemin. When this happens, the
antibodies are ‘unmasked’ to behave in vitro as autoantibodies.” Id. at 20:6–
10. The Specification discloses that “redox-reactive autoantibodies can act
as biomarkers to enable the improved understanding, diagnosis, and
treatment of . . . neurodegenerative diseases such as Alzheimer’s disease.”
Id. at 20:16–18.
Claims 1–7 and 20–25 are on appeal. Claims 1 and 25, reproduced
below, are the independent claims:
1. A method for diagnosing, monitoring and/or staging
Alzheimer’s disease which comprises:
providing a blood sample from a human subject;
oxidizing the blood sample from a human subject in
vitro; and then
conducting a blood test for determining a level of at least
one redox-reactive autoantibody in the blood sample;
comparing the level of the at least one redox-reactive
autoantibody to a predetermined value; and
diagnosing, monitoring and/or staging Alzheimer’s
disease based on the comparison between the level of the at
least one redox-reactive autoantibody and the predetermined
value.

Appeal 2020-000157
Application 12/554,497

3
25. A method for treating Alzheimer’s disease which comprises:
providing a blood sample from a human subject;
oxidizing the blood sample from a human subject in vitro; and
then
conducting a blood test for determining a level of at least one
redox-reactive autoantibody in the blood sample;
comparing the level of the at least one redox-reactive
autoantibody to a predetermined value;
diagnosing, monitoring and/or staging Alzheimer’s disease
based on the comparison between the level of the at least one redox-
reactive autoantibody and the predetermined value; and
when the patient is diagnosed with Alzheimer’s disease,
treating the human subject based on the diagnosing, monitoring and/or
staging.
OPINION
Claims 1–7 and 20–25 stand rejected under 35 U.S.C. § 101 on the
basis that they are “directed to the natural correlation between natural redox-
reactive autoantibodies and Alzheimer’s disease state,” without significantly
more. Final Action2 2–3. The Examiner states that “[t]he rationale for this
determination has been explained previously and will not be reiterated
herein.” Id. at 3.
As we understand it, the Examiner relies on the explanation of the
rejection provided most recently in the Examiner’s Answer for the previous
appeal of this application (Appeal 2017-000477, decided June 28, 2018). In
that appeal, the Examiner found that the claims “are directed to the natural
correlation between natural redox-reactive autoantibodies and a disease

2 Office Action mailed Oct. 25, 2018.
Appeal 2020-000157
Application 12/554,497

4
state” and “there are no features in addition to the exception that are more
than purely conventional or routine in the art.” Previous Ans.3 2. More
specifically, the Examiner found that “the comparing and diagnosing steps
can be mental processes and are simply drawn to the observance of nature.”
Id. at 3. The Examiner also found that “[t]he element of oxidizing the sample
is well-understood in the art and is simply mirroring that which occurs
naturally.” Id. at 3–4 (citing McIntyre ’5414 and McIntyre ’6815). “That is,
McIntyre [’541] and McIntyre [’681] both teach oxidizing bloods samples in
vitro with oxidizing agents, such as hemin.” Final Action 3.6
Appellant argues, among other things, that the claims are “eligible
under . . . the Alice/Mayo analysis because the additional elements recited in
the claims provide ‘significantly more’ than the recited judicial exception
(e.g., because the additional elements are unconventional in combination).”
Appeal Br. 8. Specifically, Appellant argues that “oxidizing a blood sample
from a human subject in vitro . . . was not was [sic] well-understood, routine,
and conventional.” Id. at 9.

3 Examiner’s Answer mailed Aug. 8, 2016.
4 McIntyre, US 2006/0141541 A1, published June 29, 2006.
5 McIntyre, US 2005/0260681 A1, published Nov. 24, 2005.
6 The Examiner also reasons that, “[b]ecause all of the claims are drawn to
the same invention that was considered by the Board and this rejection was
affirmed by the Board, the rejection is affirmed herein on the ground of res
judicata.” Final Action 4. However, we agree with Appellant (Appeal Br.
10–11) that res judicata does not apply here, because the claims have been
amended and the evidentiary record is different from what was considered in
the previous appeal. See MPEP § 706.03(w) (citing cases in which res
judicata rejections were reversed because of differences in the claims or new
evidence).
Appeal 2020-000157
Application 12/554,497

5
“In support of its position that oxidizing a blood sample from a human
subject in vitro was not was [sic] well-understood, routine, and conventional,
appellant notes the Declaration of Paul A. Hyslop Under 37 CFR §1.132
submitted August 28, 2018.” Id. Appellant points out that,
[f]or the reasons set forth in his declaration, Dr. Hyslop
concludes that the steps of oxidizing the blood sample from a
human subject in vitro, and then conducting a blood test for
determining a level of at least one redox-reactive autoantibody
in the blood sample were not, as of the effective filing date of
the invention . . . , well-understood, routine, and conventional.
Id. at 10.
Principles of Law
A. Section 101
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to
include implicit exceptions: “[l]aws of nature, natural phenomena, and
abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573
U.S. 208, 216 (2014).
In determining whether a claim falls within an excluded category, we
are guided by the Court’s two-part framework, described in Mayo and Alice.
Alice, 573 U.S. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus
Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework,
we first determine what concept the claim is “directed to.” See Alice, 573
U.S. at 219 (“On their face, the claims before us are drawn to the concept of
intermediated settlement, i.e., the use of a third party to mitigate settlement
risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4
Appeal 2020-000157
Application 12/554,497

6
in petitioners’ application explain the basic concept of hedging, or protecting
against risk.”).
If the claim is “directed to” a judicial exception—a law of nature, a
natural phenomenon, or an abstract idea—we turn to the second step of the
Alice and Mayo framework, where “we must examine the elements of the
claim to determine whether it contains an ‘inventive concept’ sufficient to
‘transform’ the claimed abstract idea into a patent-eligible application.”
Alice, 573 U.S. at 221 (quotation marks omitted). “If a law of nature is not
patentable, then neither is a process reciting a law of nature, unless that
process has additional features that provide practical assurance that the process
is more than a drafting effort designed to monopolize the law of nature itself.”
Mayo, 566 U.S. at 77.
B. USPTO Section 101 Guidance
In January 2019, the U.S. Patent and Trademark Office (USPTO)
published revised guidance on the application of § 101. 2019 Revised Patent
Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019)
(“2019 Revised Guidance”).7 “All USPTO personnel are, as a matter of
internal agency management, expected to follow the guidance.” Id. at 51; see
also October 2019 Update at 1.

7 In response to received public comments, the Office issued further
guidance on October 17, 2019, clarifying the 2019 Revised Guidance.
USPTO, October 2019 Update: Subject Matter Eligibility (the “October
2019 Update”) (available at https://www.uspto.gov/sites/default/files/
documents/peg_oct_2019_update.pdf).
Appeal 2020-000157
Application 12/554,497

7
Under the 2019 Revised Guidance and the October 2019 Update, we
first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of
abstract ideas (i.e., mathematical concepts, certain methods of
organizing human activity such as a fundamental economic
practice, or mental processes) (“Step 2A, Prong One”); and
(2) additional elements that integrate the judicial exception into
a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th
ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).8
2019 Revised Guidance, 84 Fed. Reg. at 52–55.
Only if a claim (1) recites a judicial exception and (2) does not
integrate that exception into a practical application, do we then look, under
Step 2B, to whether the claim:
(3) adds a specific limitation beyond the judicial exception that
is not “well-understood, routine, conventional” in the field (see
MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional
activities previously known to the industry, specified at a high
level of generality, to the judicial exception.
2019 Revised Guidance, 84 Fed. Reg. at 52–56.
Revised Guidance Step 2A, Prong 1
Following the Revised Guidance, we first consider whether claims 1
and 25 recite a judicial exception. Claims 1 and 25 both recite the steps of

8 This evaluation is performed by (a) identifying whether there are any
additional elements recited in the claim beyond the judicial exception, and
(b) evaluating those additional elements individually and in combination to
determine whether the claim as a whole integrates the exception into a
practical application. See 2019 Revised Guidance - Section III(A)(2), 84
Fed. Reg. at 54–55.
Appeal 2020-000157
Application 12/554,497

8
“conducting a blood test for determining a level of at least one redox-
reactive autoantibody in [a] blood sample,” “comparing the level of the at
least one redox-reactive autoantibody to a predetermined value,” and
“diagnosing, monitoring and/or staging Alzheimer’s disease based on the
comparison between the level of the at least one redox-reactive autoantibody
and the predetermined value.”
The Revised Guidance identifies “a law of nature, or a natural
phenomenon” as being among the judicial exceptions to patentability. 84 Fed.
Reg. at 54.
Here, we agree with the Examiner that the correlation between the
level of certain redox-reactive antibodies and Alzheimer’s disease is a
natural phenomenon. See Spec. 26 (“A simple rule based classifier . . .
would be: Either an OD value of hemin treated IgG PE BSA greater than
0.28 or an OD value of hemin treated IgG PE BSA less than 0.28 combined
with an OD value of hemin treated IgM PE ABP less than 0.13 indicates a
non AD patient.”).
In Mayo, the Court held that “Prometheus’ patents set forth laws of
nature—namely, relationships between concentrations of certain metabolites
in the blood and the likelihood that a dosage of a thiopurine drug will prove
ineffective or cause harm.” 566 U.S. at 77. Similarly here, Appellant’s
claims set forth laws of nature—namely, relationships between the levels of
certain redox-reactive antibodies and the likelihood that a patient suffers
from Alzheimer’s disease. Appellant’s claims recite a judicial exception to
patentability.

Appeal 2020-000157
Application 12/554,497

9
Revised Guidance Step 2A, Prong 2
Even though claims 1 and 25 recite a natural phenomenon, they would
still be patent-eligible if “the claim as a whole integrates the recited judicial
exception into a practical application of the exception.” 2019 Revised
Guidance, 84 Fed. Reg. at 54. “A claim that integrates a recited judicial
exception into a practical application will apply, rely on, or use the judicial
exception in a manner that imposes a meaningful limit on the judicial
exception, such that the claim is more than a drafting effort designed to
monopolize the judicial exception.” Id.
The analysis of determining whether the claim integrates the judicial
exception into a practical application includes “[i]dentifying whether there
are any additional elements recited in the claim beyond the judicial
exception(s)” and “evaluating those additional elements individually and in
combination to determine whether they integrate the exception into a
practical application.” Id. at 54–55.
Here, claims 1 and 25 both recite the steps of “providing a blood
sample from a human subject” and “oxidizing the blood sample from a
human subject in vitro.” The “examples in which a judicial exception has not
been integrated into a practical application” include “an additional element
[that] adds insignificant extra-solution activity,” such as mere data-
gathering, to the judicial exception. 2019 Revised Guidance, 84 Fed. Reg. at
55.
In this case, the steps of providing a blood sample and oxidizing the
blood sample in vitro amount to steps required to gather the data that is
Appeal 2020-000157
Application 12/554,497

10
needed in order to apply the natural phenomenon recited in the claims. Cf.
Mayo, 566 U.S. at 79:
Anyone who wants to make use of these laws must first
administer a thiopurine drug and measure the resulting
metabolite concentrations, and so the combination amounts to
nothing significantly more than an instruction to doctors to
apply the applicable laws when treating their patients.
The upshot is that the three steps simply tell doctors to gather
data from which they may draw an inference in light of the
correlations.
Similarly here, anyone who want to make use of the natural
correlation between Alzheimer’s disease and the level of certain redox-
reactive antibodies in a patient’s blood must collect and oxidize a blood
sample—which necessarily be done in vitro, since it is done with a blood
sample rather than with a patient. Thus, the steps of providing a blood
sample and oxidizing it are mere data gathering and do not integrate the
recited judicial exception into a practical application.
Claim 25 also adds the step of, “when the patient is diagnosed with
Alzheimer’s disease, treating the human subject based on the diagnosing,
monitoring and/or staging.” The “exemplary considerations are indicative
that an additional element . . . may have integrated the exception into a
practical application” include “an additional element that applies or uses a
judicial exception to effect a particular treatment or prophylaxis for a disease
or medical condition.” 2019 Revised Guidance, 84 Fed. Reg. at 55.
However, “[t]he treatment or prophylaxis limitation must be
‘particular,’ i.e., specifically identified so that it does not encompass all
applications of the judicial exception(s).” October 2019 Update at 14. For
example, a claim to identifying a genotype associated with poor metabolism
Appeal 2020-000157
Application 12/554,497

11
of beta blocker medications, followed by administering a suitable
medication does not add a particular administration step, “and is instead
merely instructions to ‘apply’ the exception in a generic way.” Id.
Here, the treatment step recited in claim 25 does not require any
particular treatment, but encompasses any treatment that is administered
based on the diagnosis of Alzheimer’s disease, which itself is based on the
natural correlation between Alzheimer’s disease and the level of certain
redox-reactive antibodies in a patient’s blood. Thus, the treatment step of
claim 25 amounts merely to instructions to “apply” the recited judicial
exception.
We conclude that claims 1 and 25 are directed to a natural
phenomenon.
Revised Guidance Step 2B
Finally, the Revised Guidance directs us to consider whether claim 1
includes “additional elements . . . [that] provide[] ‘significantly more’ than
the recited judicial exception.” 84 Fed. Reg. at 56. The Revised Guidance
states that an additional element that “simply appends well-understood,
routine, conventional activities previously known to the industry, specified
at a high level of generality, to the judicial exception, . . . is indicative that
an inventive concept may not be present.” Id.
However, an additional element that “[a]dds a specific limitation or
combination of limitations that are not well-understood, routine,
conventional activity in the field, . . . is indicative that an inventive concept
may be present.” Id. The Revised Guidance also states that if, for example,
an additional element was found to be insignificant extra-solution activity
Appeal 2020-000157
Application 12/554,497

12
under revised Step 2A, that conclusion should be reevaluated in Step 2B: “If
such reevaluation indicates that the element is unconventional or otherwise
more than what is well-understood, routine, conventional activity in the
field, this finding may indicate that an inventive concept is present and that
the claim is thus eligible.” Id.
“The question of whether a claim element or combination of elements
is well-understood, routine and conventional to a skilled artisan in the
relevant field is a question of fact.” Berkheimer v. HP Inc., 881 F.3d 1360,
1368 (Fed. Cir. 2018). “Whether a particular technology is well-understood,
routine, and conventional goes beyond what was simply known in the prior
art. The mere fact that something is disclosed in a piece of prior art, for
example, does not mean it was well-understood, routine, and conventional.”
Id. at 1369.
“In rejecting an application, factual determinations by the PTO must
be based on a preponderance of the evidence.” In re Oetiker, 977 F.2d 1443,
1449 (Fed. Cir. 1992) (J. Plager, concurring). In this case, the Examiner cites
two of the present inventor’s own published patent applications as evidence
that “oxidizing bloods samples in vitro with oxidizing agents, such as
hemin” is “routine and conventional in the art.” Final Action 3.
In response, Appellant has provided the Hyslop Declaration.
Appellant argues that “the Declaration of Paul A. Hyslop Under 37 CFR
§1.132 demonstrates that oxidizing a blood sample from a human subject in
vitro was not was [sic] well-understood, routine, and conventional.” Appeal
Br. 10.
Appeal 2020-000157
Application 12/554,497

13
We agree with Appellant that the Examiner has not shown, by a
preponderance of the evidence, that oxidizing a blood sample from a human
subject in vitro and conducting a blood test to determine the level of redox-
reactive autoantibody in the blood sample, as recited in both independent
claims on appeal, was well-understood, routine, and conventional.
We find that Dr. Hyslop is well-qualified, by education and
experience, to provide an opinion on whether the assay method recited in the
claims was well-understood, routine, and conventional. Dr. Hyslop states
that he “performed extensive literature surveys to establish that only the
inventor and his associates published scientific papers between 2004–2007
using the inventor’s technology.” Hyslop Decl. 19 (footnotes omitted). Dr.
Hyslop also states that his “extensive literature surveys found only two other
laboratories published publications, which relate to modification of purified
IgG . . . that pre-date the filing of the provisional.” Id. at 2.10 Dr. Hyslop
states that, in both cases, the publications describe oxidation of purified IgG,
rather than blood samples. Id.
Dr. Hyslop “conclude[s] that the steps of oxidizing the blood sample
from a human subject in vitro, and then conducting a blood test for
determining a level of at least one redox-reactive autoantibody in the blood
sample were not, as of the effective filing date of the invention . . . , well-
understood, routine, and conventional.” Id. at 2–3.

9 The first page of the declaration in not numbered, so the second page of the
declaration is numbered “1” and the following pages are numbered
sequentially from there.
10 The instant application claims the benefit of provisional application
61/094,167, filed Sept. 4, 2008. Spec. 1.
Appeal 2020-000157
Application 12/554,497

14
We conclude that the Examiner’s position is not supported by a
preponderance of the evidence. As noted above, the Examiner relies solely
on evidence that the inventor himself practiced the recited assay steps prior
to the effective filing date of the instant application. The fact that the
inventor may have described the assay in published patent applications is not
sufficient evidence that the assay was well-understood, routine, and
conventional. See Berkheimer, 881 F.3d at 1369 (“Whether a particular
technology is well-understood, routine, and conventional goes beyond what
was simply known in the prior art. The mere fact that something is disclosed
in a piece of prior art, for example, does not mean it was well-understood,
routine, and conventional.”).
This is particularly true where, as here, Appellant has submitted
declaratory evidence to show that prior to the effective filing date, only two
other laboratories had published related assay methods, and even those
examples used purified IgG rather than a blood sample, as required by the
claims.
The Examiner responds that, in the previous appeal of this application,
the Board concluded that “it was known and conventional in the art to
unmask autoantibodies with an oxidizing agent.” Ans. 4–5. The conclusion,
however, was made based on a different evidentiary record. “After evidence
or argument is submitted by the applicant in response [to a rejection],
patentability is determined on the totality of the record, by a preponderance
of evidence with due consideration to persuasiveness of argument.” In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). As discussed above, we
Appeal 2020-000157
Application 12/554,497

15
conclude that the rejection on appeal is not supported by a preponderance of
the evidence now in the record.
The Examiner also concludes that “[t]he declaration is merely offering
an opinion on the ultimate legal conclusion at issue and the declaration does
not provide any compelling evidence, facts or data consistent with
applicant’s conclusion.” Ans. 5. This reasoning, however, does not take into
account the entire Hyslop Declaration, which provides not only Dr. Hyslop’s
opinion but also the evidentiary basis for that opinion: the limited examples
of similar assay methods described in the scientific literature that were
carried out by laboratories other than the inventor’s. The Examiner has not
provided evidence that contradicts the evidence cited by Dr. Hyslop.
In summary, we conclude that “additional elements recited in the
claims provide[] ‘significantly more’ than the recited judicial exception
(e.g., because the additional elements [a]re unconventional in combination).”
2019 Revised Guidance, 84 Fed. Reg. at 56. We therefore reverse the
rejection of claims 1–7 and 20–25 under 35 U.S.C. § 101.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–7, 20–25 101 Eligibility 1–7, 20–25

REVERSED

Appeal 2020-000157
Application 12/554,497

16
FREDMAN, Administrative Patent Judge, dissenting.

I respectfully dissent from the Majority’s opinion and would affirm
the Examiner’s rejection under 35 U.S.C. § 101.
The Majority finds, under the Revised Guidance, Step 2A, Prong 1,
that the claims encompass a correlation that is a natural phenomenon and
therefore a judicial exception to patentability. The Majority finds, under the
Revised Guidance, Step 2A, Prong 2, that “the steps of providing a blood
sample and oxidizing it are mere data gathering and do not integrate the
recited judicial exception into a practical application.” Dec. supra.
However, under the Revised Guidance, Step 2B, citing Berkheimer,
and based in part on the Hyslop Declaration, the Majority finds that the
evidence fails to establish that “oxidizing a blood sample from a human
subject in vitro and conducting a blood test to determine the level of redox-
reactive autoantibody in the blood sample, as recited in both independent
claims on appeal, was well-understood, routine, and conventional.” Dec.
supra.
I dissent both as to the meaning of “well-understood, routine, and
conventional” and as to the application of that test to the instant facts.
Berkheimer states that “whether a claim element or combination of elements
is well-understood, routine and conventional to a skilled artisan in the
relevant field is a question of fact.” Berkheimer v. HP Inc., 881 F.3d 1360,
1368 (Fed. Cir. 2018). As the Majority pointed out, Berkheimer also states
that the “mere fact that something is disclosed in a piece of prior art, for
example, does not mean it was well-understood, routine, and conventional.”
Id. at 1369. However, “[e]vidence of the state of the art . . . consists of proof
Appeal 2020-000157
Application 12/554,497

17
of what was old and in general use at the time of the alleged invention. It is
received . . . to show what was then old, [and] to distinguish what was new.”
Brown v. Piper, 91 U.S. 37, 41 (1875). Thus, while disclosure in a single
piece of prior art might not, in some cases, be sufficient to satisfy the “well-
understood, routine, and conventional,” I would find that disclosure in
multiple prior art references and review articles reasonably demonstrates that
an element is “well-understood, routine, and conventional.”
In this case, even Appellant’s Declarant Dr. Hyslop acknowledges
that the technology was being performed in three different laboratories and
was published in 9 separate journal articles prior to the filing date of the
instant application (see Hyslop Decl. 1–2). Dr. Hyslop failed to further note
that two additional publications, the McIntyre ’54111 and McIntyre ’68112
patents were both published prior to the filing date of the instant application.
Dr. Hyslop also failed to particularly address the teachings of these
references,13 specifically the disclosure in McIntyre et al., Redox-reactive
autoantibodies: detection and physiological relevance, 5 Autoimmunity
Reviews 76–83 (2006)14 that “we made concerted efforts to enlist the help of
other investigators who have proven and documented proficiencies in testing
for specified autoantibodies to analyze our redox-reacted and control
serum/plasma samples” (McIntyre 77, col. 1). “Other laboratories, selected

11 McIntyre, US 2006/0141541 A1, published June 29, 2006.
12 McIntyre, US 2005/0260681 A1, published Nov. 24, 2005.
13 I note that consideration of rebuttal evidence cited for its persuasive power
does not constitute a New Ground of Rejection. See ICOS Corp. v. Actelion
Pharm. Ltd, 726 F. App’x 812, 817 (Fed. Cir. 2018).
14 This reference is identified in footnote #4 of the Hyslop Declaration.
Appeal 2020-000157
Application 12/554,497

18
by us for their respective expertise, have studied our redox-reacted and
control serum and/or antibody preparations and have found an expanding
array of autoantibody specificities” (McIntyre 76, abstract). Thus, the
asserted inventive technology was not limited to Dr. McIntyre’s laboratory,
but was made well-known to other investigators. McIntyre further notes,
relevant to the instant claims, that “[i]t will be interesting to study the
concentrations of these masked and unmasked antibodies to phospholipids in
CSF of patients with diseases of the central nervous system, such as
Alzheimer’s disease.” (McIntyre 80, col. 1).
Therefore, based both on Dr. Hyslop’s statement that multiple labs
were aware of the technology and the disclosure in the McIntyre
Autoimmunity Reviews paper that a number of labs were enlisted and
disclosed the claimed technology, I conclude that the technology is “well-
understood, routine, and conventional.” I would therefore affirm the
Examiner’s rejection under 35 U.S.C. § 101.